Senior Aseptic Fill/Finish Project Leader

EFOR; Sligo; On-site; EUR 90,000 - 130,000; Full time

Job summary

EFOR Group in Sligo, Ireland, is seeking a Senior Project Engineer specialized in aseptic filling to lead capital projects in a center of excellence for fill/finish. You will drive scope, design, commissioning, qualification, and handover to Operations, partnering with Quality, Validation, and Automation teams.

The role requires 7+ years in pharmaceutical/biologics manufacturing, hands-on aseptic processing experience, and strong project-management and stakeholder skills.

Qualifications

• Bachelor's or Master's in Engineering (Mechanical, Chemical, Biotech, or related discipline).
• 7+ years' experience in pharmaceutical/biologics manufacturing with project/process engineering roles.
• Proven track record delivering capital projects in sterile/aseptic environments (vial filling lines, isolators, lyophilizers).
• Knowledge of cGMP, Annex 1, FDA/EMA and validation lifecycle (URS, DQ, IQ, OQ, PQ, PPQ).
• Hands-on familiarity with aseptic processing technology (isolators/RABS, filling systems, lyophilization) and biologics handling.
• Project management skills: budget ownership, scheduling, vendor management, cross-functional leadership.
• Strong stakeholder management, communication, problem-solving; able to lead technical discussions.
• PMP or Lean/Six Sigma certification is advantageous.

Responsibilities

• Lead capital and process improvement projects from scope through commissioning and handover.
• Drive equipment introduction and tech transfer for isolator-based lines and lyophilizers.
• Own project engineering deliverables: URS, FAT/SAT, IOQ/PQ, risk assessments.
• Act as technical lead and single point of contact for cross-functional stakeholders.
• Manage contractors, vendors, and internal resources; track budgets and timelines.
• Support investigations and CAPA resolution for equipment/process deviations.
• Ensure work complies with cGMP, Annex 1, and site EHS requirements.

Skills

Project management

Stakeholder management

Communication

Problem-solving

Cross-functional leadership

cGMP knowledge

Education

Engineering degree (Bachelor's or Master's)

Job description

EFOR Group in Sligo, Ireland, is seeking a Senior Project Engineer specialized in aseptic filling to lead capital projects in a center of excellence for fill/finish. You will drive scope, design, commissioning, qualification, and handover to Operations, partnering with Quality, Validation, and Automation teams.

The role requires 7+ years in pharmaceutical/biologics manufacturing, hands-on aseptic processing experience, and strong project-management and stakeholder skills.